S-ROM 2576-00-008Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10603295145301), received between Aug 10, 2017 and Jun 25, 2024 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (4 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 25, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE CONE REAMER EXTENSION HAND WILL NO LONGER HOLD THE CONE REAMERS. UNKNOWN SURGICAL DELAY.

  Patient problems: Insufficient Information

  MAUDE report 19603893 ↗
• MalfunctionNov 9, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE SROM WHITE SLEEVE WOULD NOT CONNECT TO ANY OF THE CONE MILLING REAMERS. THE WHITE T HANDLE WOULD NOT CONNECT TO ANY OF THE DISTAL REAMERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18107121 ↗
• MalfunctionMay 7, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED AS "INSTRUMENTS WERE USED IN SURGERY. UPON INSPECTION OF THOSE INSTRUMENTS THIS MORNING, (B)(6) , WE NOTICED SOME DEFECTS IN THE TWO SLEEVE TRIALS MAKING IT DIFFICULT TO USE WITH THE "SLEEVE INTRODUCER" HANDLE. WE ALSO INSPECTED THE REAMER HANDLE AND IT WAS DIFFICULT TO LOCK ON THE CONICAL REAMERS. THESE ISSUES WERE NOT MENTIONED IN SURGERY, HOWEVER, AFTER SPEAKING WITH THE SURGICAL TECH TODAY, (B)(6) , HE ASKED ME TO TAKE A LOOK." NO SURGICAL DELAY

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11794033 ↗
• MalfunctionApr 3, 2020Scratched Material; Illegible Information; Scratched Material; Illegible Information

  IT WAS REPORTED THAT THE INSTRUMENTS ARE SCRATCHED UP OR DAMAGED AND SIZES CAN¿T BE READ OR IDENTIFIED EASILY. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9919394 ↗
• MalfunctionApr 3, 2020Scratched Material; Illegible Information; Scratched Material; Illegible Information

  IT WAS REPORTED THAT THE INSTRUMENTS ARE SCRATCHED UP OR DAMAGED AND SIZES CAN'T BE READ OR IDENTIFIED EASILY. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9919391 ↗
• MalfunctionApr 2, 2019Break; Device Damaged Prior to Use; Device-Device Incompatibility; Break; Device Damaged Prior to Use; Device-Device Incompatibility

  THE REAMER EXTENSION WAS NOT COMPATIBLE WITH THE PROXIMAL REAMERS AND IS DAMAGED. THESE HAD NO EFFECT ON SURGERY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8475780 ↗
• MalfunctionSep 28, 2018Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT BUTTON ON EXTENSION WAS STUCK AND WILL NOT ALLOW REAMER OR DRILL TO ATTACH.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7919030 ↗
• MalfunctionAug 10, 2017Connection Problem; Connection Problem

  IT WAS REPORTED THAT THE CONE REAMER EXTENSION IS NOT CONNECTING WITH REAMERS.

  Patient problems: No Information

  MAUDE report 6783944 ↗